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Senior Quality Engineer

2 months ago


Bloomington, United States Donaldson Full time

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We are seeking a Senior Quality Engineer to join our Product Development team at Donaldson Company. This role requires an experienced and self-motivated problem solver with a strong sense of responsibility and ownership for the successful outcome of individual and team efforts. In this role, you are our expert in Good Manufacturing Practices and ISO9001 requirements. You will be challenged to ensure the correct processes are developed and implemented. You will oversee implementation of control plans to secure long term success. You will be a key member on a product development team.

Role Responsibilities (other duties may be assigned as needed):

  • Own, build and implement a Quality Management System for a newly commercialized product and research and development

  • Own the development and implementation of standard operating procedures and processes to meet ISO 9001 requirements

  • Identify process gaps, develop and implement quality plans and monitor progress towards quality goals and objectives

  • Lead root cause investigations for product failure or variation in the process and provide quantifiable results

  • Identify and implement engineering solutions for actions resulting from root cause investigations

  • Support team in process improvements and incorporate statistical thinking

  • Lead team in continuous improvement initiatives and drive efforts related to improving product quality and minimizing process variation

  • Present findings to all levels of leadership providing recommendations and solutions

  • Perform internal quality audits and work with 3rd party auditors to ensure conformance with established procedures and processes

  • Effectively achieves corrective action through proven problem-solving techniques to provide ongoing feedback for quality improvement

  • Develop and maintain effective working relationships with local and global partners

  • Stay current with quality advancements in industry and introduce new perspectives

Minimum Qualifications:

  • Bachelor's degree in engineering (Chemical, Material Science, Manufacturing, Mechanical or Industrial)

  • 5+ years of experience in a manufacturing or product development environment directly involved with quality, or equivalent combination of education and experience.

  • Experience in regulated quality management system

  • Advanced computer literacy skills, Proficient in Minitab, JMP or similar statistical analysis software

  • Demonstrated ability to lead cross functional teams, developing common processes and driving standardized practices

Preferred Qualifications:

  • Manufacturing and/or product development experience, including SPC, DOE, FMEA, and DMAIC problem solving

  • Strong organizational skills and attention to detail

  • Ability to recognize problems/opportunities and recommend/implement solutions

  • Ability to manage multiple projects simultaneously

Key words: GMP, QMS, Quality Management System, Minitab, JMP, ISO 9001

Employment opportunities for positions in the United States may require use of information which is subject to the export control regulations of the United States. Hiring decisions for such positions are required by law to be made in compliance with these regulations. Applicants for employment opportunities in other countries must be able to meet the comparable export control requirements of that country and of the United States.

Our policy is to provide equal employment opportunities to all qualified persons without regard to race, gender, color, disability, national origin, age, religion, union affiliation, sexual orientation, veteran status, citizenship, gender identity and/or expression, or other status protected by law.